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OpenTrials
Completed

NCT Number: NCT04343092

Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management

Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)

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Key information

Conditions

COVID 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

General Directorate of Medical City

Baghdad, Baghdad Governorate, 964, Iraq

About this study

Comparing effectiveness of single dose 0.2mg/kg Ivermectin (IVM) plus hydroxychloroquine (HCQ) 400mg BID in first day then 200mg BID for 5 days plus azithromycin (AZT) 500mg in first day then 250mg for 5 days.

The comparison group was a historical control population and data collected from the current study were compared to that historical control population

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-1. Patients with age above 18 years and any gender with definite Dx of covid19 and pneumonia in the ward according to the clinical, laboratory, and imaging criteria.

  • Understands and agrees to comply with planned study procedures.

Exclusion criteria

  • Patients with hypersensitivity or severe adverse effects to Ivermectin
  • Renal impairment
  • Hepatic impairment.
  • Pregnancy or a desire to become pregnant (drug considered pregnancy category c)
  • Breast feeding.
  • Patient with covid 19 positive and mild no pneumonia
  • Children under the age of five or those who weigh less than 15 kilograms

Treatment and study plan

ivermectin (IVM)

Drug

Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly

Other names: Ivermectin

Primary outcomes

  1. Number of Cured Patients

    Time frame: 4 weeks

    Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab.

Secondary outcomes

  1. Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group

    Time frame: 4 week

    Time to cure is evaluated by measuring time from admission of the patient to the hospital till discharge after being free of symptoms and negative PCR swab. Once nasopharyngeal and oropharyngeal swab viral PCR testing yielded negative results 2 times consecutively, no further testing was performed

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (An Externally Controlled Pilot Trial)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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